Experience

Swissmedic

• Switzerland
• Government Administration
• 200 - 300 Employee

• Regulatory Manager ATMPs

  • Oct 2023 - Present



CSL

• Australia
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Global Regulatory Affairs Europe

  • Jan 2023 - Sep 2023

  See "Senior Manager Regulatory Affairs Europe" section below. In addition: - Development of the EU regulatory strategy for gene therapy product within Haematology TA, including PIP, ODD, ATMP, PRIME, HTA consultation (since 09.2022) - Recruitment, on-boarding and supervision of Regulatory Intern

• Senior Manager, Global Regulatory Affairs Europe

  • Aug 2017 - Dec 2022

  - Development of the regional regulatory strategy for various clinical development programs within the TA Immunology - Responsible for EU Health Authorities interactions - Regional support for life cycle management encompassing labelling optimization, CMC projects, Clinical and Safety related submissions - Supervision of EU module 1 preparation - Advising classification for complex changes/variations according to EU guidelines/experience, liaising with HA when necessary



Merck Healthcare

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager, Global Regulatory Affairs CMC

  • Apr 2015 - May 2017

  Same description as below. In addition: recruiting, managing and developing direct reporting employee

• Manager, Global Regulatory Affairs CMC

  • Apr 2012 - Apr 2015

  - Management of regulatory CMC regulatory files preparation worldwide (US, EU, China, Japan, Latam, Asia-Pacific etc.) for clinical trials (phases II-III) and life-cycle management products: oncology (monoclonal antibody, therapeutic vaccine), fertility and endocrinology (small peptides / chemicals) - Assessment of regulatory impact for CMC changes worldwide (except Japan and China) - Participation to comparability protocols and reports writing - Planning for CMC submissions on a year… Show more - Management of regulatory CMC regulatory files preparation worldwide (US, EU, China, Japan, Latam, Asia-Pacific etc.) for clinical trials (phases II-III) and life-cycle management products: oncology (monoclonal antibody, therapeutic vaccine), fertility and endocrinology (small peptides / chemicals) - Assessment of regulatory impact for CMC changes worldwide (except Japan and China) - Participation to comparability protocols and reports writing - Planning for CMC submissions on a year basis, setting priorities - Managing projects for major CMC changes (change of API supplier, change of API peptide synthesis, change of manufacturing site etc.) - Response to Health Authorities CMC requests/questions - Elaboration of briefing books for scientific advice meetings with EMA, FDA, PEI and MHRA - Participation to the elaboration of the Quality by Design strategy with identification of CQA, CPP and Control Strategy



Merck Healthcare

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Specialist, Global Regulatory Affairs CMC

  • Aug 2008 - Feb 2011

  - Regulatory CMC dossiers preparation and writing for clinical trial applications (phase III), line extensions and variations worldwide: endocrinology (recombinant) - Responses to CMC questions from Health Authorities worldwide, pharmacists, physicians and patients - Regulatory review of Change Control Proposals (CCPs) as described by manufacturing sites, consolidating regulatory impact and planning submissions - Audited Quality Documentation versus data generated at and activities… Show more - Regulatory CMC dossiers preparation and writing for clinical trial applications (phase III), line extensions and variations worldwide: endocrinology (recombinant) - Responses to CMC questions from Health Authorities worldwide, pharmacists, physicians and patients - Regulatory review of Change Control Proposals (CCPs) as described by manufacturing sites, consolidating regulatory impact and planning submissions - Audited Quality Documentation versus data generated at and activities performed by the manufacturing sites (including GMP documentation) - Ensured current knowledge of regulatory environment and therapeutic area and provided feedback to upper management on specific new regulations Show less - Regulatory CMC dossiers preparation and writing for clinical trial applications (phase III), line extensions and variations worldwide: endocrinology (recombinant) - Responses to CMC questions from Health Authorities worldwide, pharmacists, physicians and patients - Regulatory review of Change Control Proposals (CCPs) as described by manufacturing sites, consolidating regulatory impact and planning submissions - Audited Quality Documentation versus data generated at and activities… Show more - Regulatory CMC dossiers preparation and writing for clinical trial applications (phase III), line extensions and variations worldwide: endocrinology (recombinant) - Responses to CMC questions from Health Authorities worldwide, pharmacists, physicians and patients - Regulatory review of Change Control Proposals (CCPs) as described by manufacturing sites, consolidating regulatory impact and planning submissions - Audited Quality Documentation versus data generated at and activities performed by the manufacturing sites (including GMP documentation) - Ensured current knowledge of regulatory environment and therapeutic area and provided feedback to upper management on specific new regulations Show less



Alcimed

• France
• Business Consulting and Services
• 200 - 300 Employee

• Life Science Consultant

  • Nov 2007 - Jun 2008

  Worked on various projects in the Pharma-Biotech and Food industries, including: - Strategic marketing studies - Regulatory dossiers preparation, writing and recommendations - Business Intelligence investigations Worked on various projects in the Pharma-Biotech and Food industries, including: - Strategic marketing studies - Regulatory dossiers preparation, writing and recommendations - Business Intelligence investigations